Trial Outcomes & Findings for A Research Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102 (NCT NCT03613662)
NCT ID: NCT03613662
Last Updated: 2022-01-13
Results Overview
Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in plasma cortisol levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
12 Weeks
Results posted on
2022-01-13
Participant Flow
Participant milestones
| Measure |
SP-102
SP-102
SP-102: Injection
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Research Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102
Baseline characteristics by cohort
| Measure |
SP-102
n=19 Participants
SP-102
SP-102: Injection
|
|---|---|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 14.42 • n=93 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Height
|
166.51 cm
STANDARD_DEVIATION 12.294 • n=93 Participants
|
|
Weight
|
84.03 kg
STANDARD_DEVIATION 16.412 • n=93 Participants
|
|
BMI
|
30.51 kg/m^2
STANDARD_DEVIATION 6.127 • n=93 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: 19 subjects were enrolled and received an index (T1) injection of SP-102. 15 subjects received a (T2) injection of SP-102. Data was not recorded for all subjects at each time point.
Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in plasma cortisol levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks
Outcome measures
| Measure |
SP-102
n=19 Participants
SP-102
SP-102: Injection
|
|---|---|
|
Change in Plasma Cortisol Concentrations From Baseline
T1: Day 1 (predose)
|
36.62 nmol/L
Standard Deviation 31.81
|
|
Change in Plasma Cortisol Concentrations From Baseline
T1: Day 2
|
0.64 nmol/L
Standard Deviation 0.27
|
|
Change in Plasma Cortisol Concentrations From Baseline
T1: Day 3
|
6.26 nmol/L
Standard Deviation 9.00
|
|
Change in Plasma Cortisol Concentrations From Baseline
T1: Day 4
|
29.77 nmol/L
Standard Deviation 2.60
|
|
Change in Plasma Cortisol Concentrations From Baseline
T1: Day 5
|
39.91 nmol/L
Standard Deviation 40.53
|
|
Change in Plasma Cortisol Concentrations From Baseline
T1: Day 8
|
39.71 nmol/L
Standard Deviation 28.97
|
|
Change in Plasma Cortisol Concentrations From Baseline
T1: Day 15
|
44.28 nmol/L
Standard Deviation 33.55
|
|
Change in Plasma Cortisol Concentrations From Baseline
T1: Day 28
|
25.08 nmol/L
Standard Deviation 21.34
|
|
Change in Plasma Cortisol Concentrations From Baseline
T2: Day 1 (predose)
|
38.81 nmol/L
Standard Deviation 41.10
|
|
Change in Plasma Cortisol Concentrations From Baseline
T2: Day 2
|
0.64 nmol/L
Standard Deviation 0.23
|
|
Change in Plasma Cortisol Concentrations From Baseline
T2: Day 3
|
3.68 nmol/L
Standard Deviation 3.85
|
|
Change in Plasma Cortisol Concentrations From Baseline
T2: Day 4
|
50.71 nmol/L
Standard Deviation 56.21
|
|
Change in Plasma Cortisol Concentrations From Baseline
T2: Day 5
|
38.35 nmol/L
Standard Deviation 35.00
|
|
Change in Plasma Cortisol Concentrations From Baseline
T2: Day 8
|
41.73 nmol/L
Standard Deviation 38.95
|
|
Change in Plasma Cortisol Concentrations From Baseline
T2: Day 15
|
73.31 nmol/L
Standard Deviation 97.64
|
|
Change in Plasma Cortisol Concentrations From Baseline
T2: Day 28
|
28.18 nmol/L
Standard Deviation 20.34
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: 19 subjects were enrolled and received an index (T1) injection of SP-102. 15 subjects received a (T2) injection of SP-102. Data was not recorded for all subjects at each time point.
Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in blood glucose levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks
Outcome measures
| Measure |
SP-102
n=19 Participants
SP-102
SP-102: Injection
|
|---|---|
|
Change in Blood Glucose Levels From Baseline
T1: Day 1 (predose)
|
4.993 nmol/L
Standard Deviation 0.5216
|
|
Change in Blood Glucose Levels From Baseline
T1: Day 2
|
6.155 nmol/L
Standard Deviation 0.9009
|
|
Change in Blood Glucose Levels From Baseline
T1: Day 3
|
4.528 nmol/L
Standard Deviation 0.4451
|
|
Change in Blood Glucose Levels From Baseline
T1: Day 4
|
4.676 nmol/L
Standard Deviation 0.5509
|
|
Change in Blood Glucose Levels From Baseline
T1: Day 5
|
4.958 nmol/L
Standard Deviation 0.4362
|
|
Change in Blood Glucose Levels From Baseline
T1: Day 8
|
5.059 nmol/L
Standard Deviation 0.6597
|
|
Change in Blood Glucose Levels From Baseline
T1: Day 15
|
5.254 nmol/L
Standard Deviation 0.8143
|
|
Change in Blood Glucose Levels From Baseline
T1: Day 28
|
4.963 nmol/L
Standard Deviation 0.7116
|
|
Change in Blood Glucose Levels From Baseline
T2: Day 1 (predose)
|
4.867 nmol/L
Standard Deviation 0.5655
|
|
Change in Blood Glucose Levels From Baseline
T2: Day 2
|
5.865 nmol/L
Standard Deviation 0.8673
|
|
Change in Blood Glucose Levels From Baseline
T2: Day 3
|
4.581 nmol/L
Standard Deviation 0.4986
|
|
Change in Blood Glucose Levels From Baseline
T2: Day 4
|
4.850 nmol/L
Standard Deviation 0.8078
|
|
Change in Blood Glucose Levels From Baseline
T2: Day 5
|
4.959 nmol/L
Standard Deviation 0.5791
|
|
Change in Blood Glucose Levels From Baseline
T2: Day 8
|
4.821 nmol/L
Standard Deviation 0.4463
|
|
Change in Blood Glucose Levels From Baseline
T2: Day 15
|
5.237 nmol/L
Standard Deviation 0.8394
|
|
Change in Blood Glucose Levels From Baseline
T2: Day 28
|
4.945 nmol/L
Standard Deviation 0.5959
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: 19 subjects were enrolled and received an index (T1) injection of SP-102. 15 subjects received a (T2) injection of SP-102. Data was not recorded for all subjects at each time point.
Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in WBC levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks
Outcome measures
| Measure |
SP-102
n=19 Participants
SP-102
SP-102: Injection
|
|---|---|
|
Change in White Blood Cell (WBC) Levels From Baseline
T1: Day 1 (predose)
|
6.65 cell count × 10^9/L
Standard Deviation 2.051
|
|
Change in White Blood Cell (WBC) Levels From Baseline
T1: Day 2
|
13.43 cell count × 10^9/L
Standard Deviation 3.726
|
|
Change in White Blood Cell (WBC) Levels From Baseline
T1: Day 3
|
9.33 cell count × 10^9/L
Standard Deviation 2.336
|
|
Change in White Blood Cell (WBC) Levels From Baseline
T1: Day 4
|
7.38 cell count × 10^9/L
Standard Deviation 1.863
|
|
Change in White Blood Cell (WBC) Levels From Baseline
T1: Day 5
|
6.81 cell count × 10^9/L
Standard Deviation 1.771
|
|
Change in White Blood Cell (WBC) Levels From Baseline
T1: Day 8
|
6.91 cell count × 10^9/L
Standard Deviation 2.212
|
|
Change in White Blood Cell (WBC) Levels From Baseline
T1: Day 15
|
7.26 cell count × 10^9/L
Standard Deviation 1.873
|
|
Change in White Blood Cell (WBC) Levels From Baseline
T1: Day 28
|
6.15 cell count × 10^9/L
Standard Deviation 1.339
|
|
Change in White Blood Cell (WBC) Levels From Baseline
T2: Day 1 (predose)
|
6.77 cell count × 10^9/L
Standard Deviation 1.865
|
|
Change in White Blood Cell (WBC) Levels From Baseline
T2: Day 2
|
13.43 cell count × 10^9/L
Standard Deviation 4.517
|
|
Change in White Blood Cell (WBC) Levels From Baseline
T2: Day 3
|
9.21 cell count × 10^9/L
Standard Deviation 3.199
|
|
Change in White Blood Cell (WBC) Levels From Baseline
T2: Day 4
|
7.88 cell count × 10^9/L
Standard Deviation 2.302
|
|
Change in White Blood Cell (WBC) Levels From Baseline
T2: Day 5
|
7.28 cell count × 10^9/L
Standard Deviation 2.087
|
|
Change in White Blood Cell (WBC) Levels From Baseline
T2: Day 8
|
7.31 cell count × 10^9/L
Standard Deviation 2.803
|
|
Change in White Blood Cell (WBC) Levels From Baseline
T2: Day 15
|
8.05 cell count × 10^9/L
Standard Deviation 3.592
|
|
Change in White Blood Cell (WBC) Levels From Baseline
T2: Day 28
|
6.07 cell count × 10^9/L
Standard Deviation 1.541
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 19 subjects were enrolled and received an index (T1) injection of SP-102. 15 subjects received a (T2) injection of SP-102. Data was not recorded for all subjects at each time point.
The NPRS is an 11-point scale (0- to 10-point scale where 0 is no pain and 10 is worst pain imaginable) that allows subjects to rate the severity of their pain intensity at various points in time (Turk et al., 2003). Subjects used the NPRS to record their current pain, average pain over 24 hours, and worst pain over 24 hours for both affected leg(s) and back pain. NPRS average leg pain scores over 24 hours are presented.
Outcome measures
| Measure |
SP-102
n=19 Participants
SP-102
SP-102: Injection
|
|---|---|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline
T1: Baseline (pre-dose)
|
5.4 score on a scale
Standard Deviation 1.30
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline
T1: Day 1
|
5.3 score on a scale
Standard Deviation 1.29
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline
T1: Day 2
|
3.2 score on a scale
Standard Deviation 1.84
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline
T1: Day 3
|
2.2 score on a scale
Standard Deviation 1.61
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline
T1: Day 4
|
2.5 score on a scale
Standard Deviation 2.14
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline
T1: Day 5
|
2.3 score on a scale
Standard Deviation 2.21
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline
T1: Day 8
|
2.5 score on a scale
Standard Deviation 2.37
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline
T1: Day 15
|
3.2 score on a scale
Standard Deviation 2.48
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline
T1: Day 28
|
3.4 score on a scale
Standard Deviation 1.80
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline
T2: Baseline (pre-dose)
|
5.4 score on a scale
Standard Deviation 1.18
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline
T2: Day 1
|
5.2 score on a scale
Standard Deviation 1.32
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline
T2: Day 2
|
3.5 score on a scale
Standard Deviation 2.36
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline
T2: Day 3
|
1.9 score on a scale
Standard Deviation 1.28
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline
T2: Day 4
|
2.1 score on a scale
Standard Deviation 1.58
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline
T2: Day 5
|
1.9 score on a scale
Standard Deviation 1.53
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline
T2: Day 8
|
2.2 score on a scale
Standard Deviation 2.21
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline
T2: Day 15
|
2.4 score on a scale
Standard Deviation 2.21
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline
T2: Day 28
|
2.9 score on a scale
Standard Deviation 2.46
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 19 subjects were enrolled and received an index (T1) injection of SP-102. 15 subjects received a (T2) injection of SP-102. Data was not recorded for all subjects at each time point.
The NPRS is an 11-point scale (0- to 10-point scale where 0 is no pain and 10 is worst pain imaginable) that allows subjects to rate the severity of their pain intensity at various points in time (Turk et al., 2003). Subjects used the NPRS to record their current pain, average pain over 24 hours, and worst pain over 24 hours for both affected leg(s) and back pain. NPRS average back pain scores over 24 hours are presented.
Outcome measures
| Measure |
SP-102
n=19 Participants
SP-102
SP-102: Injection
|
|---|---|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline
T1: Baseline (pre-dose)
|
5.2 score on a scale
Standard Deviation 1.46
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline
T1: Day 1
|
5.2 score on a scale
Standard Deviation 1.50
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline
T1: Day 2
|
3.5 score on a scale
Standard Deviation 2.14
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline
T1: Day 3
|
2.3 score on a scale
Standard Deviation 1.45
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline
T1: Day 4
|
2.7 score on a scale
Standard Deviation 2.11
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline
T1: Day 5
|
2.6 score on a scale
Standard Deviation 2.39
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline
T1: Day 8
|
2.8 score on a scale
Standard Deviation 2.48
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline
T1: Day 15
|
3.2 score on a scale
Standard Deviation 2.46
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline
T1: Day 28
|
3.9 score on a scale
Standard Deviation 1.90
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline
T2: Baseline (pre-dose)
|
5.4 score on a scale
Standard Deviation 1.35
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline
T2: Day 1
|
5.3 score on a scale
Standard Deviation 1.35
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline
T2: Day 2
|
3.5 score on a scale
Standard Deviation 2.33
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline
T2: Day 3
|
2.1 score on a scale
Standard Deviation 1.55
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline
T2: Day 4
|
2.8 score on a scale
Standard Deviation 1.81
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline
T2: Day 5
|
2.3 score on a scale
Standard Deviation 1.35
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline
T2: Day 8
|
2.4 score on a scale
Standard Deviation 2.03
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline
T2: Day 15
|
2.9 score on a scale
Standard Deviation 1.96
|
|
Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline
T2: Day 28
|
3.2 score on a scale
Standard Deviation 2.27
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 19 subjects were enrolled and received an index (T1) injection of SP-102. 15 subjects received a (T2) injection of SP-102.
Incidence of treatment-emergent AEs (TEAEs) related to study drug.
Outcome measures
| Measure |
SP-102
n=19 Participants
SP-102
SP-102: Injection
|
|---|---|
|
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Treatment 1
|
20 events
|
|
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Treatment 2
|
10 events
|
Adverse Events
SP-102
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SP-102
n=19 participants at risk
SP-102
SP-102: Injection
|
|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.3%
1/19 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
1/19 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.3%
1/19 • 12 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
10.5%
2/19 • 12 weeks
|
|
Gastrointestinal disorders
Food poisoning
|
5.3%
1/19 • 12 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal refluxdisease
|
5.3%
1/19 • 12 weeks
|
|
General disorders
Pain
|
5.3%
1/19 • 12 weeks
|
|
Infections and infestations
Bronchitis
|
5.3%
1/19 • 12 weeks
|
|
Infections and infestations
Nasopharyngitis
|
10.5%
2/19 • 12 weeks
|
|
Infections and infestations
Respiratory tract infection
|
5.3%
1/19 • 12 weeks
|
|
Infections and infestations
Tooth abscess
|
10.5%
2/19 • 12 weeks
|
|
Investigations
Blood glucose increased
|
5.3%
1/19 • 12 weeks
|
|
Investigations
White blood cell count increased
|
5.3%
1/19 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
1/19 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.3%
1/19 • 12 weeks
|
|
Nervous system disorders
Headache
|
36.8%
7/19 • 12 weeks
|
|
Nervous system disorders
Migraine
|
5.3%
1/19 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.3%
1/19 • 12 weeks
|
Additional Information
Associate Director Clinical Operations
Scilex Pharmaceuticals, Inc.
Phone: 6503866709
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor has the right to first publication of the results of the study. Following the first publication, PIs may publish study data or results; however, the proposed publication must be submitted to the Sponsor for review and approval in writing at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study Data.
- Publication restrictions are in place
Restriction type: OTHER